Complaint Remediation Quality Tech
About The Position
Accountable for customer complaint investigations and outcomes. Coordinate servicing, issues replacements or credits to customer. Job Description MAJOR RESPONSIBILITIES: Review and remediate historical product complaints to ensure completeness, accuracy, and compliance with updated regulatory and internal standards. Conduct retrospective investigations utilizing available data sources such as historical records, sample evaluations, image reviews, and trend analyses. Analyze updated investigation findings to ensure accurate root cause and draft clear, concise complaint updates based on results. Prepare and revise complaint records, including analysis summaries, closure statements, and remediation justifications. Apply updated procedural guidelines to identify complaints requiring escalation, including initiation of Corrective and Preventive Actions (CAPA), Supplier Corrective Action Requests (SCAR), or Health Hazard Evaluations (HHE), based on trend analysis and reclassification outcomes. Education: High School Diploma/Equivalent with 3+ year of experience in Quality within the Medical Device or Pharma Industry OR Bachelor’s degree in a relevant field with demonstrated experience handling product complaints in a regulated professional environment.
Requirements
- High School Diploma/Equivalent with 3+ year of experience in Quality within the Medical Device or Pharma Industry OR Bachelor’s degree in a relevant field with demonstrated experience handling product complaints in a regulated professional environment.
- Strong cross-functional collaboration skills and ability to manage multiple tasks under critical deadlines.
- Strong analytical, critical thinking and problem-solving abilities with attention to detail.
- Basic proficiency with Microsoft Office Suite (Word, Excel, PowerPoint)
Nice To Haves
- 2+ years of experience with product complaint remediation efforts in a regulated industry
- Experience supporting efforts associated with or responding to FDA/ISO findings
- Experience with SAP or similar complaint investigation software
Responsibilities
- Review and remediate historical product complaints to ensure completeness, accuracy, and compliance with updated regulatory and internal standards.
- Conduct retrospective investigations utilizing available data sources such as historical records, sample evaluations, image reviews, and trend analyses.
- Analyze updated investigation findings to ensure accurate root cause and draft clear, concise complaint updates based on results.
- Prepare and revise complaint records, including analysis summaries, closure statements, and remediation justifications.
- Apply updated procedural guidelines to identify complaints requiring escalation, including initiation of Corrective and Preventive Actions (CAPA), Supplier Corrective Action Requests (SCAR), or Health Hazard Evaluations (HHE), based on trend analysis and reclassification outcomes.
Benefits
- Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
- Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
- For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
Number of Employees
5,001-10,000 employees
